MedPath

Efficacy of Marine By-product Hydrolysate on the Reduction of Atopic Dermatitis Symptoms

Not Applicable
Completed
Conditions
Atopic Dermatitis
Eczema
Registration Number
NCT06268847
Lead Sponsor
Abyss Ingredients
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Inclusion Criteria:<br><br> - Phototype: I to V;<br><br> - Subjects with atopic skin (with at least 1 visible xerosis + inflammation on the<br> body);<br><br> - Subjects with a history background of asthma, rhinitis and/or allergic<br> conjunctivitis;<br><br> - Subjects with SCORAD between 8 and 30 (at least 50% or more having around 8-10);<br><br> - Subjects with BMI between 20 and 30 kg/m2 (limits included);<br><br> - Subjects who have not recently participated in another similar study;<br><br> - Willingness to take supplements for the duration of the study;<br><br> - Willingness not to use products likely to interfere with the test product (collagen,<br> hyaluronic acid, anti-stress products);<br><br> - Willingness not to change lifestyle habits;<br><br> - Willingness to avoid intensive UV exposure;<br><br> - Use of contraception that should not be modified during the study.<br><br> - Healthy subject;<br><br> - Mentally healthy subject according to Investigator's opinion;<br><br> - Subject having given his/her free informed, written consent;<br><br> - Subject agrees to taking photograph and then use the image after its<br> pseudonymization;<br><br> - Subject willing to adhere to the protocol and study procedures;<br><br> - Subject able to understand the study;<br><br> - Subject available to attend the study visits.<br><br>Exclusion Criteria:<br><br> - Pregnant or nursing woman or woman planning to get pregnant during the study;<br><br> - Cutaneous marks on the experimental areas, which could interfere with the assessment<br> of skin reactions;<br><br> - Subjects who have participated in the last 3 months or are currently participating<br> in another clinical trial that may interfere with the evaluation of the primary<br> endpoint (endpoint AD);<br><br> - Current administration of antibiotics;<br><br> - Known history of chronic disease such as congenital heart disease, liver or kidney<br> disease, or immune deficiency;<br><br> - Topical treatment with immunomodulators (tacrolimus or pimecrolimus) in the three<br> months prior to registration;<br><br> - Application of moisturizing products on the experimental area the day of the<br> inclusion of the study;<br><br> - Acute or chronic infectious diseases;<br><br> - Not meet inclusion criteria;<br><br> - Those undergoing aesthetic medicine (fillers, hyaluronic acid injections, botox)<br> that could interference in the experimental area;<br><br> - Subjects suffering Alimentary/Eating disorders (i.e. bulimia, psychogenic eating<br> disorders, etc.)<br><br> - Subjects having frequent stomach burn;<br><br> - Allergy or intolerance to any ingredient of the experimental food supplement;<br><br> - Subjects with diabetes mellitus;<br><br> - Fish and/or iodine allergy;<br><br> - Intestinal conditions or disorders (Crohn's disease, colitis, irritable bowel<br> syndrome, intestinal malabsorption...)<br><br> - Recent change, forecast of initiation of an hormonal treatment or change of the<br> usual hormonal treatment during the study or 3 months before the starting of the<br> study;<br><br> - Subject having undergone a surgery under general anesthesia within the previous<br> month;<br><br> - Exposure in UVA ray sunbed during the 3 months before the start of the study on the<br> experimental area or during the study;<br><br> - Subjects protected by the law;<br><br> - Subject employed by EUROFINS PRODUCT TESTING, COSMETICS & PERSONAL CARE SPAIN,<br> S.L.U.

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
SCORAD (SCORing Atopic Dermatitis)
Secondary Outcome Measures
NameTimeMethod
EASI (Eczema Area and Severity Index);Investigator Global Assessment scale;Corneometer;Transepidermal Water Loss (TEWL);Quality of Life Index - Perceived Stress;Participant's Satisfaction
© Copyright 2025. All Rights Reserved by MedPath